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Postoperative Effects of Different Enterostomy Approaches

Primary Purpose

Colorectal Cancer, Colorectal Neoplasms Malignant, Intestinal Neoplasms, Malignant

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ileostomy
Transverse colostomy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Stoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathological confirmed adenocarcinoma of the rectum; Patients age between 18-80; Baseline AJCC stage I-III: cT1-4N0-2M0 (AJCC-8 version); Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2; Patients voluntarily sign informed consent. Exclusion Criteria: Other types of rectal cancer (adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma); Combination of rectal cancer with multiple carcinomas; Pre-operative presence of acute and chronic infectious diseases or foci of infection; Intraoperative radical surgery was not performed for various reasons; Colostomy was not performed at the same time as the radical rectal cancer surgery; Combined with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery; Metastatic cancer; Serious heart, lung, liver and kidney disease, can not tolerate surgery; Active liver disease or abnormal liver function with ALT, AST and TBIL more than 2 times the upper limit of normal values; Renal impairment with Cr ≥ 2 times the upper limit of normal or BUN ≥ 2 times the upper limit of normal; Blood leukocytes below the lower limit of normal value, or platelets below the lower limit of normal value, or with other blood system diseases; Pregnancy; Mental illness or serious intellectual disability who cannot describe their feelings correctly; Severe coagulation disorder, bleeding tendency; Patients with severe uncontrolled medical disease, recent history of myocardial infarction (within 3 months), uncontrolled severe hypertension and severe diabetes mellitus; Patients need to be on antibiotics/other probiotics for a long time.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ileostomy

Transverse colostomy

Arm Description

Protective ileostomy as a defunction mean after low anterior resection

Protective transverse colostomy as a defunction mean after low anterior resection

Outcomes

Primary Outcome Measures

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing

Secondary Outcome Measures

Concentration of inflammatory markers
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Changes in cellular immunity status
Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry
Changes in humoral immunity status
Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry
Incidence of anastomotic leakage
The occurrence of postoperative anastomotic leakage
Early postoperative complications rate
Incidence of postoperative complications such as diarrhea, intestinal obstruction, incisional infection, stoma prolapse, stoma necrosis, parastomal hernia, irritant dermatitis, renal insufficiency, etc.
First intestinal gas time
Documenting the patient's post-operative recovery
First defecation time
Documenting the patient's post-operative recovery
Concentration of inflammatory markers
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Changes in cellular immunity status
Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry
Changes in humoral immunity status
Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry
Incidence of grade 3-4 serious side effects of adjuvant chemotherapy
Assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Adjuvant chemotherapy toxicity and quality of life scores
Assessed with European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29), ranging from 29 to 116 and higher scores suggest worse quality of life
Concentration of inflammatory markers
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Changes in cellular immunity status
Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry
Changes in humoral immunity status
Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry
Disease-free Survival
Time between the start of surgical randomization and recurrence of disease or death (from any cause)Time between the start of surgical randomization and recurrence of disease or death (from any cause)
Overall Survival
Time from the start of surgical randomization to death (from any cause)

Full Information

First Posted
April 10, 2023
Last Updated
May 17, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05853094
Brief Title
Postoperative Effects of Different Enterostomy Approaches
Official Title
A Single-centre, Randomized Study to Compare the Outcomes of Protected Transverse Colostomy Versus Ileostomy After Low Anterior Resection of Low Rectal Cancer From the Perspective of Intestinal Microecology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Exploring the effect of protective ileostomy compared with transverse colostomy on the occurrence of complications, the occurrence of serious side effects of adjuvant chemotherapy and disease recurrence in patients with low rectal cancer after radical surgery from the perspective of intestinal microecology.
Detailed Description
Low rectum refers to the rectal area <7 cm from the anal verge. At present, with the development of modern medical technology and the change of surgical concept, more and more patients can achieve the goal of radical treatment of low rectal cancer while preserving the anus. The occurrence of anastomotic leakage after anus-preserving surgery for low-grade rectal cancer is a more common and serious complication, with an incidence ranging from 2.4% to 15.9%, and the morbidity and mortality rate after anastomotic leakage can be as high as 16%. A protective stoma protects the anastomosis by temporarily establishing an artificial channel above the anastomosis to divert feces and avoid mechanical pressure and contamination of the anastomosis by intestinal contents, allowing the anastomosis to grow and heal in relatively clean external conditions. The current choices of protective stoma sites are terminal ileum and transverse colon. Analysis of domestic and international studies shows that both protective transverse colostomy and ileostomy can achieve the effect of diversion of stool, but whether there is a difference in preventing anastomotic leakage and reducing adverse outcomes of anastomotic leakage remains to be investigated. There are significant inconsistencies between domestic and international studies regarding the incidence of stoma-related complications caused by different stoma sites: the study by Rondelli et al. showed that terminal ileostomy was associated with lower stoma-related complications, and a domestic meta-analysis recommended terminal ileostomy after radical rectal cancer surgery. In contrast, the study by the team from the Union Hospital showed that transverse colostomy was associated with significantly lower rates of stoma-related complications and perioperative complications of stoma reentry. In addition, according to the Union Hospital team study, the incidence of postoperative intestinal microbiota dysbiosis was higher in patients who underwent ileostomy compared to those who underwent transverse colostomy. The total intestinal microbiota in the colon accounts for more than 90% of the systemic intestinal microbiota, and the intestinal microbiota in the large intestine can be roughly restored to preoperative levels after transverse colostomy, whereas a large amount of intestinal microbiota is lost and difficult to restore after ileostomy. The dominant flora in the colon, such as Clostridium and Enterococcus, are less likely to colonize the small intestine, which may adversely affect the intestinal and systemic immune regulation and antitumor immune effects of the body. In addition, patients with progressive low-grade rectal cancer routinely require adjuvant chemotherapy after radical surgery, and there are no studies at domestic or abroad on whether terminal ileostomy, which is more common than transverse colostomy for intestinal dysbiosis, has any differences on the efficacy and toxic side effects of adjuvant chemotherapy for patients; furthermore, it is also important to investigate whether the two different stoma methods have an impact on long-term disease recurrence and overall survival of patients. In addition, whether the two different stoma modalities have an effect on long-term disease recurrence and overall survival is also an important research question. Therefore, the investigators propose to conduct a prospective, randomized, controlled study in patients with low-grade rectal cancer who underwent radical surgery (with or without neoadjuvant radiotherapy) to investigate whether there are differences in the incidence of complications, serious side effects of adjuvant chemotherapy, and disease recurrence after terminal ileostomy versus transverse colostomy from the perspective of intestinal microecology, and to explore the differences in systemic immunity, inflammatory, and metabolic status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms Malignant, Intestinal Neoplasms, Malignant
Keywords
Colorectal Cancer, Stoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ileostomy
Arm Type
Experimental
Arm Description
Protective ileostomy as a defunction mean after low anterior resection
Arm Title
Transverse colostomy
Arm Type
Experimental
Arm Description
Protective transverse colostomy as a defunction mean after low anterior resection
Intervention Type
Procedure
Intervention Name(s)
Ileostomy
Intervention Description
Protective loop ileostomy after low anterior resection
Intervention Type
Procedure
Intervention Name(s)
Transverse colostomy
Intervention Description
Protective loop transverse colostomy after low anterior resection
Primary Outcome Measure Information:
Title
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Description
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Time Frame
1 month
Title
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Description
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Time Frame
6 months
Title
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Description
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Concentration of inflammatory markers
Description
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Time Frame
1 month
Title
Changes in cellular immunity status
Description
Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry
Time Frame
1 month
Title
Changes in humoral immunity status
Description
Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry
Time Frame
1 month
Title
Incidence of anastomotic leakage
Description
The occurrence of postoperative anastomotic leakage
Time Frame
1 month
Title
Early postoperative complications rate
Description
Incidence of postoperative complications such as diarrhea, intestinal obstruction, incisional infection, stoma prolapse, stoma necrosis, parastomal hernia, irritant dermatitis, renal insufficiency, etc.
Time Frame
1 month
Title
First intestinal gas time
Description
Documenting the patient's post-operative recovery
Time Frame
1 month
Title
First defecation time
Description
Documenting the patient's post-operative recovery
Time Frame
1 month
Title
Concentration of inflammatory markers
Description
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Time Frame
6 month
Title
Changes in cellular immunity status
Description
Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry
Time Frame
6 month
Title
Changes in humoral immunity status
Description
Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry
Time Frame
6 month
Title
Incidence of grade 3-4 serious side effects of adjuvant chemotherapy
Description
Assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
6 month
Title
Adjuvant chemotherapy toxicity and quality of life scores
Description
Assessed with European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29), ranging from 29 to 116 and higher scores suggest worse quality of life
Time Frame
6 months
Title
Concentration of inflammatory markers
Description
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Time Frame
3 years
Title
Changes in cellular immunity status
Description
Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry
Time Frame
3 years
Title
Changes in humoral immunity status
Description
Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry
Time Frame
3 years
Title
Disease-free Survival
Description
Time between the start of surgical randomization and recurrence of disease or death (from any cause)Time between the start of surgical randomization and recurrence of disease or death (from any cause)
Time Frame
3 years
Title
Overall Survival
Description
Time from the start of surgical randomization to death (from any cause)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathological confirmed adenocarcinoma of the rectum; Patients age between 18-80; Baseline AJCC stage I-III: cT1-4N0-2M0 (AJCC-8 version); Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2; Patients voluntarily sign informed consent. Exclusion Criteria: Other types of rectal cancer (adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma); Combination of rectal cancer with multiple carcinomas; Pre-operative presence of acute and chronic infectious diseases or foci of infection; Intraoperative radical surgery was not performed for various reasons; Colostomy was not performed at the same time as the radical rectal cancer surgery; Combined with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery; Metastatic cancer; Serious heart, lung, liver and kidney disease, can not tolerate surgery; Active liver disease or abnormal liver function with ALT, AST and TBIL more than 2 times the upper limit of normal values; Renal impairment with Cr ≥ 2 times the upper limit of normal or BUN ≥ 2 times the upper limit of normal; Blood leukocytes below the lower limit of normal value, or platelets below the lower limit of normal value, or with other blood system diseases; Pregnancy; Mental illness or serious intellectual disability who cannot describe their feelings correctly; Severe coagulation disorder, bleeding tendency; Patients with severe uncontrolled medical disease, recent history of myocardial infarction (within 3 months), uncontrolled severe hypertension and severe diabetes mellitus; Patients need to be on antibiotics/other probiotics for a long time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanlei Ma, PhD
Phone
(86)13122680635
Email
yanleima@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yichi Zhang, MD
Phone
(86)18588731911
Email
22111230058@m.fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanlei Ma, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanlei Ma, PhD
Phone
(86)13122680635
Email
yanleima@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Yichi Zhang, MD
Phone
(86)18588731911
Email
22111230058@m.fudan.edu.cn

12. IPD Sharing Statement

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Postoperative Effects of Different Enterostomy Approaches

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